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Federal forms, ICRs, and supporting documents

Information Collection Request

Third Party Disclosure and Recordkeeping Requirements For Reportable Food

ICR 201002-0910-004 · OMB 0910-0643 · Historical Inactive

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-02-26
IC Document Collections
IC ID
Document
Title
Status
192136 New
192135 New
192134 New
192133 New
189627 Modified
189626 Modified
ICR Details
0910-0643 201002-0910-004
Historical Inactive 200906-0910-002
HHS/FDA
Third Party Disclosure and Recordkeeping Requirements For Reportable Food
Extension without change of a currently approved collection   No
Regular
Withdrawn and continue 05/05/2010
Retrieve Notice of Action (NOA) 02/26/2010
Withdrawn at the request of FDA.
  Inventory as of this Action Requested Previously Approved
02/28/2010 36 Months From Approved 11/30/2010
6,000 0 6,000
3,180 0 3,180
0 0 0
Section 1005 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) amends the Federal Food, Drug, and Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), among other things. Section 417 of the act defines "reportable food" as an "article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals." (Section 417(a)(2) of the act). Section 417 of the act requires FDA to establish an electronic portal (the Reportable Food electronic portal) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. FDA made the decision that the most efficient and cost effective means to implement the requirements of section 417 of the act relating to the Registry was to utilize the business enterprise system currently under development within the agency: the MedWatchPlus Portal. In addition, Section 1005(f) of FDAAA required FDA to issue guidance to industry about submitting reports through the electronic portal of instances of reportable food and providing notifications to other persons in the supply chain of such article of food. FDA is issuing guidance containing questions and answers relating to the requirements under section 417 of the act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.
US Code: 21 USC 350f Name of Law: FFDCA
  
US Code: 21 USC 350f Name of Law: FFDCA
Not associated with rulemaking
  74 FR 53746 10/20/2009
75 FR 8960 02/26/2009
Yes
No
No
Program change increase for 150 hours due to maintenance of records for voluntary reports.
$350
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659
  No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
02/26/2010